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Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient , drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.
A labeler is any firm that manufactures, repacks or distributes a drug product. The second segment, the product code, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional ...
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The GPI defines Drug Group, Drug Class, Drug Subclass, Drug Base Name, Drug Name, Dose Form, and GPI Name in a codified manner. The first six characters of the GPI define the therapeutic class code, the next two pairs the drug name, and the last four define route, dosage or strength.
Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs).
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: